FDA advisors unanimously vote to approve Moderna's mRNA after agency drama

Independent advisors for the Food and Drug Administration on Friday voted 9–0 in support of approving Moderna's seasonal m RNA flu vaccine, which a Trump appointee at the agency initially tried to block from even being reviewed. In an all-day meeting, members of the FDA's advisory committee—known as VRBPAC for Vaccines and Related Biological Products Advisory Committee—pored over data and presentations on the vaccine, which is dubbed m RNA-1010 and branded as m Flusiva. The presentations included a review from FDA scientists, which was supportive of the vaccine. Data from a Phase 3 trial including over 40,000 adults age 50 and older found the mRNA vaccine was around 27 percent more effective against seasonal flu than a standard flu shot. A smaller Phase 3 trial, involving data from nearly 3,000 people age 65 years and older, showed the shot produces stronger immune responses than a high-dose flu vaccine, which is recommended for this age group. The safety profile of the vaccine was also generally good.Read full article Comments